68 FR 71 pg. 17881 - Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction
Type: RULEVolume: 68Number: 71Page: 17881
Docket number: [Docket No. 76N-052G]
FR document: [FR Doc. 03-9067 Filed 4-11-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 341
[Docket No. 76N-052G]
RIN 0910-AA01
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; correction.
SUMMARY:
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of December 23, 2002 (67 FR 78158). The document issued a final monograph that established conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products.
DATES:
The regulation is effective December 23, 2004.
FOR FURTHER INFORMATION CONTACT:
Cazemiro R. Martin or Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
SUPPLEMENTARY INFORMATION:
In FR Doc. 02-32158 appearing on page 78158 in the Federal Register of Monday, December 23, 2002, the following corrections are made:
§ 341.40 [Corrected]
1. On page 78168, in the second column, in Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use , under the authority citation, in amendment 2, "Section 341.40 is added to subpart C to read as follows:" is corrected to read "Section 341.40 is added to subpart B to read as follows:"
§ 341.70 [Corrected]
2. On page 78170, in the second column, in § 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product) , in paragraph (b), "Repeat every hour as needed or as directed by a doctor." is corrected to read "Repeat every 2 hours as needed or as directed by a doctor."
Dated: April 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9067 Filed 4-11-03; 8:45 am]
BILLING CODE 4160-01-S